An interventional study of liver transplant in Hepatocellular Carcinoma, Scirrhous and Recurrence Tumor, sponsored by Centro Hospitalar de Lisboa Central. Recruiting at 1 site in Portugal. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2022-06-06.
Sponsored by Centro Hospitalar de Lisboa Central · Not applicable, Interventional, and Treatment
Liver transplant is the most effective treatment for hepatocellular carcinoma (HCC) in cirrhosis. Due to organs shortage, the proper selection of patients is imperative. Prevailing clinical morphological models used in most centres (Milan Criteria), can exclude potential candidates and include patients with aggressive biological behaviour. To more accurately select candidates for liver transplant, the inclusion of criteria that could predict the behaviour and aggressiveness of tumours, such as molecular markers, might be useful.
The investigators propose the use of a new algorithm (HepatoPredict Prognostic Tool), that combine clinical and molecular criteria that address the biology of tumours, in a single centre prospective, intervention study. Data from the "HepatoPredict genomic signature" are added to the clinical and imagiology algorithm. Based on this tool, patients outside the usual eligibility criteria for liver transplant will be proposed for this treatment. These patients will be transplanted with marginal livers or with livers from patients with Familial Amyloid Polyneuropathy, not competing with patients on the waiting list. Patients will be followed up to 60 months after transplant, to assess survival and HCC recurrence with biannual imagiology screening. Survival and disease-free-survival rates will be compared with those obtained by the usual management of patients included and excluded by Milan Criteria.
Liver transplant is the most effective treatment for hepatocellular carcinoma (HCC) in cirrhosis. Due to organs shortage, the proper selection of patients is imperative. Prevailing clinical morphological models used in most centres (Milan Criteria), can exclude potential candidates and include patients with aggressive biological behaviour. To more accurately select candidates for liver transplant, the inclusion of criteria that could predict the behaviour and aggressiveness of tumours, such as molecular markers, might be useful. The investigators propose the use of a new algorithm (HepatoPredict Prognostic Tool, Ophiomics), combining morphologic information, clinical and molecular criteria, in a prospective, intervention, single centre study.
Patients aged 18 to 70 years, with HCC in cirrhosis, not eligible for liver transplant under the "Milan Criteria", whom had the following morphologic characteristics: total tumour volume below 500 cm3, total number of tumour lesions below 10 and maximum individual tumour diameter below 10 cm, will be proposed for the "HepatoPredict genomic signature" analysis (Ophiomics), obtained from DNA of tumor samples. Those considered candidates by the algorithm are to be proposed for transplant with marginal livers or with livers from patients with Familial Amyloid Polyneuropathy.
Patients will be followed up to 60 months after transplant, to assess survival and HCC recurrence with biannual imagiology screening by triphasic CT scan. Additionally, circulating tumour DNA will be assessed previously to the transplant and biannually for up to 60 months. Survival and disease-free-survival rates will be compared with those obtained with the usual management of patients included and excluded by Milan Criteria, both in the same referral transplant center and in the published literature.
3,251 studies on the registry are indexed under Carcinoma, Hepatocellular; 976 are open to participants now.
This study's planned enrollment of 40 is below the median of 55 across 2,349 interventional studies indexed under Carcinoma, Hepatocellular.
Browse Carcinoma, Hepatocellular studies →Centro Hospitalar de Lisboa Central is the lead sponsor of 15 studies on the registry; 6 are open to participants now.
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Exclusion Criteria:
patients with hepatocellular carcinoma, outside the "Milan Criteria", that complied with the proposed HepatoPredictTool, submitted to liver transplant
Procedure: liver transplant
liver transplant
death
death by any cause
Time frame: from 6 months after liver transplant up to 60 months
hepatocellular carcinoma recurrence
identification of hepatocellular carcinoma recurrence through biannual triphasic CT scan
Time frame: from 6 months after liver transplant up to 60 months
hepatocellular carcinoma recurrence through liquid biopsy
early identification of hepatocellular carcinoma DNA through biannual serum samples (liquid biopsy)
Time frame: from 6 months after liver transplant up to 60 months
Plan to share: No
No publications or documents are linked to this record.
Started Mar 2021 (actual). Primary completion is estimated for Oct 2028, 91 months after the start.
Of 337 non-industry interventional studies with no phase under Carcinoma, Hepatocellular, half reached primary completion within 50 months of starting (the median), counting those still running; a quarter within 27 and three quarters within 75. This study's planned 91 months is above that.
Counting every sponsor, half of 357 studies reached it within 48 months; a quarter within 23 and three quarters within 75.
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Centro Hospitalar de Lisboa Central